NCT02392442

Brief Summary

Background: \- When bacteria enter the lungs, serious infections can occur. Researchers want to learn more about the process of inflammation in the lungs by studying lung cells and the products that they make. Lung cells are influenced by infections, smoking, and molecules made within the body. Researchers also want to learn more about one of these molecules, called microRNA (or micro ribonucleic acid). Objective: \- To better how the body responds to infection. Also, to understand which cells in the lung secrete microRNA and how they may influence other lung cells. Eligibility: \- Healthy, non-smoking adults ages 18-45. Design:

  • Participants will be screened with a medical history and physical exam. They will have blood and urine tests and an electrocardiogram.
  • Participants will have blood drawn from an arm vein. They will have an intravenous catheter (small plastic tube) placed in a vein.
  • All participants will have bronchoscopy with bronchoalveolar lavage. They will be numbed with medicine. A thin flexible tube will be placed through the nasal passages or the mouth into the airways of the lung.
  • Some participants will have bronchoscopy with bronchoalveolar lavage (rinsing the airways with salt water) in order to obtain cells from lung. The water will then be suctioned out.
  • Some participants will have two bronchoscopies; during the first procedure, endotoxin, a molecule found in bacteria is squirted into a small portion of the lung. Endotoxin is a molecule that acts like an infection but isn t one. After 6 to 48 hours, bronchoscopy with with bronchoalveolar lavage will be done to look at the lung s response to endotoxin.
  • Participants heart rhythm and rate, temperature and blood oxygen level will be monitored during the procedures.
  • Participants will be called the next day to see how they are feeling.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
14mo left

Started Jun 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2015Jun 2027

First Submitted

Initial submission to the registry

March 18, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 18, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 22, 2026

Status Verified

April 20, 2026

Enrollment Period

12 years

First QC Date

March 18, 2015

Last Update Submit

April 21, 2026

Conditions

Acute Lung Inflammation

Keywords

immunophenotypesBronchoalveolar LavageBronchoscopyEndotoxin InstallationniRNA

Outcome Measures

Primary Outcomes (1)

  • Identification of cell-associated and secreted miRNA with specific types of resident and inflammatory cells in the lung.

    Identification of cell-associated and secreted miRNA.

    6, 24, or 48 hours after Endotoxin is instilled in the lung.

Study Arms (4)

1 - Endotoxin

EXPERIMENTAL

6 hour lavage post endotoxin

Biological: Endotoxin

2 - Endotoxin

EXPERIMENTAL

24 hour lavage post endotoxin

Biological: Endotoxin

3 - Endotoxin

EXPERIMENTAL

48 hour lavage post endotoxin

Biological: Endotoxin

4 Placebo comparator

PLACEBO COMPARATOR

6 hour control lavage

Other: Saline

Interventions

SalineOTHER

Investigate the changes in miRNA signatures found in BAL and lung cells from healthy volunteers at baseline and at 6 hours after 1800 of normal Saline installed in six 30 mL aliquots into the left (lingual) and right (middle lobe) lung segments (360 mL total).

4 Placebo comparator
EndotoxinBIOLOGICAL

Investigate the changes in miRNA signatures found in BAL and lung cells from healthy volunteers at baseline and at 6, 24, or 48 hours after endotoxin segmental lung challenge.

1 - Endotoxin2 - Endotoxin3 - Endotoxin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy 18 to 45 year old, nonsmoking subjects based on screening examination and laboratory tests.
  • No significant active medical problems. This would include but not be limited to any cardiac disorder (e.g. arrhythmia, valvular heart disease), pulmonary disease (e.g. asthma requiring chronic medications, chronic bronchitis, emphysema), neurologic disorder (e.g.
  • epilepsy), kidney disease (e.g. nephritis, nephrosis), rheumatologic disorder (e.g. inflammatory arthritis), endocrine disorder (e.g. diabetes, thyroid disease), liver disease (e.g. hepatitis), gastrointestinal disorder (e.g. inflammatory bowel disease) or infectious
  • disease (e.g. human immunodeficiency virus).
  • No concurrent medications including aspirin or non-steroidal anti-inflammatory drugs or have not taken these for at least 7 days prior to study participation.
  • Previous smokers would have to have abstained from cigarettes for at least one year and have no greater than a 10-pack year smoking history. If you use a hookah, e-cigarette, or vaping more than once a week, you must abstain for at least 6 weeks prior to participating in the study.
  • Females must be practicing active method of birth control or abstinence of sexual activity.
  • Must be willing to have samples stored

You may not qualify if:

  • Any serious active medical problem as defined above
  • Pregnancy and/or lactation
  • BMI \>30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • O'Grady NP, Preas HL, Pugin J, Fiuza C, Tropea M, Reda D, Banks SM, Suffredini AF. Local inflammatory responses following bronchial endotoxin instillation in humans. Am J Respir Crit Care Med. 2001 Jun;163(7):1591-8. doi: 10.1164/ajrccm.163.7.2009111.

    PMID: 11401879BACKGROUND

  • Janssen O, Schaumann F, Holz O, Lavae-Mokhtari B, Welker L, Winkler C, Biller H, Krug N, Hohlfeld JM. Low-dose endotoxin inhalation in healthy volunteers--a challenge model for early clinical drug development. BMC Pulm Med. 2013 Mar 28;13:19. doi: 10.1186/1471-2466-13-19.

    PMID: 23537365BACKGROUND

  • Sandstrom T, Bjermer L, Rylander R. Lipopolysaccharide (LPS) inhalation in healthy subjects increases neutrophils, lymphocytes and fibronectin levels in bronchoalveolar lavage fluid. Eur Respir J. 1992 Sep;5(8):992-6.

    PMID: 1426208BACKGROUND

Related Links

MeSH Terms

Interventions

Sodium ChlorideEndotoxins

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Anthony F Suffredini, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 19, 2015

Study Start

June 18, 2015

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04-20

Locations

US(1)